Flagship Pioneering Unveils Sonata Therapeutics to Harness Cellular Microenvironments for the Treatment of Serious Diseases

On May 18th, 2022, Inzen Therapeutics merged with Cygnal Therapeutics to create Sonata Therapeutics (Press release, Inzen Therapeutics, MAY 18, 2022, View Source [SID1234635157]).

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Despite the recognized importance of the microenvironment to biology and disease, the networks of its inputs, constituents, and targets have never been fully characterized or understood. Sonata’s product-platform creates drugs based on a systematic, comprehensive characterization of the microenvironment in diseases with high unmet medical need.

Through its pioneering science, Sonata identifies new targets for therapeutics that induce the release of a programmed diversity of signals that drive curative microenvironments. Sonata uses a combination of proprietary pharmacologic and genetic perturbations, high-throughput and co-culture assays, phenotypic analyses, and machine learning, to enable target discovery.

Sonata is generating a growing pipeline of small molecule drugs and genetic therapeutics. Currently, the company’s pipeline includes six preclinical programs that address a broad range of oncologic indications, as well as exploratory efforts in fibrosis and autoimmune disorders.

"Sonata is taking an exciting and innovative approach to unlocking the enormous value potential of the cellular microenvironment," said Doug Cole, M.D., Managing Partner at Flagship and Chairman of Sonata’s Board of Directors. "It has the scale, technology, and team to translate the longstanding promise of the microenvironment into therapeutics that help patients with serious diseases."

Sonata Therapeutics was formed by combining two Flagship companies, Inzen Therapeutics and Cygnal Therapeutics, and builds on each company’s pioneering work characterizing different inputs into the cellular microenvironment and their roles in causing disease, and developing therapeutic strategies based on these insights.

Noubar Afeyan, Ph.D., Flagship Pioneering Founder and CEO, added, "Flagship’s focus on pioneering breakthroughs in human health, is embodied in the groundbreaking work of both Inzen and Cygnal. As the companies grew and their science advanced, their shared vision to reprogram the cellular microenvironment became clear. Sonata combines the expertise, resources, and vision of both companies to build a single stronger entity."

Former Inzen Chief Executive Officer, Volker Herrmann, M.D., has taken on the role of Sonata’s CEO. Former Cygnal CEO, Pearl Huang, Ph.D., recently announced her departure from the company to pursue new opportunities.

Volker Herrmann, M.D., Sonata CEO and Flagship Pioneering CEO-Partner added, "Remodeling the microenvironment requires the simultaneous control of a diversity of signals. Sonata Therapeutics’ unique approach harnesses these signals to develop curative treatments for serious diseases. I look forward to overseeing and accelerating Sonata’s growth and its transformative approach to medicine."

DEFENCE’S NOVEL ACCUVAC-PTE7 VACCINE SHOWS COMPLETE PROTECTION FROM CERVICAL CANCER

On May 18, 2022 Defence Therapeutics Inc. ("Defence" or the "Company"), a Canadian biopharmaceuticals company primarily focussed on the development of novel immune-oncology vaccines and drug delivery technologies, is pleased to reported the development of novel dual-acting AccumTM-linked protein vaccine, AccuVAC-PTE7, dedicated to protect from cervical cancer (prophylactic vaccine) or to treat (therapeutic vaccine) patients with pre-established cervical tumors (Press release, Defence Therapeutics, MAY 18, 2022, View Source [SID1234626249]).

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The protection from cervical cancer can currently only be achieved with the use of Gardasil-9 or Cervarix, two vaccines directed against the L1 proteins of HPV. However, there is currently no cure for patients with established cervical cancer and the clinical trials conducted previously with other companies with both the E6 and E7 proteins were highly disappointing.

Since the AccumTM molecule was previously shown to significantly enhance the immunogenicity of various proteins, the Defence team engineered a novel protein-based vaccine targeting the oncogenic protein E7 normally used by HPV to transform healthy cells into an outgrowing tumor. Pre-clinical studies conducted on this new vaccine, AccuVAC-PTE7, not only provide a 100% protection from cervical cancer if delivered prophylactically (e.g. before tumor growth), but also show potent anti-tumoral effects against established tumors when combined with various immunecheckpoint blockers such as anti-PD-1, anti-CTLA4 or anti-CD47.

"The idea of having a dual-acting vaccine targeting cervical cancer capable of both protecting and treating patients from cervical cancer is a giant step in the field of cancer vaccines. In addition, this vaccine contains a single protein, the E7, which makes it easier to manufacture and use compared to a mix of 9 proteins as provided by the Gardasil-9 product", says Mr. Plouffe, the CEO of Defence Therapeutics.

According to Fortune Business Insights, the global HPV vaccine market size was valued at $3.80 Bn in 2019 & is projected to reach $12.69 Bn by 2027, with a CAGR of 16.3%

Outlook Therapeutics to Present at the H.C. Wainwright Global Investment Conference

On May 18, 2022 Outlook Therapeutics, Inc. (Nasdaq: OTLK), a pre-commercial biopharmaceutical company working to develop and launch the first FDA-approved ophthalmic formulation of bevacizumab for use in retinal indications, reported that Lawrence Kenyon, Chief Financial Officer of Outlook Therapeutics, will present at the H.C. Wainwright Global Investment Conference being held May 23-26, 2022 in Miami, FL and virtually (Press release, Outlook Therapeutics, MAY 18, 2022, View Source [SID1234616060]).

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In addition to the presentation, management will be available to participate in virtual one-on-one meetings with qualified members of the investor community who are registered to attend the conference. For more information, please visit the conference website.

A video webcast of the presentation will be accessible for viewing on-demand beginning on Tuesday, May 24, 2022, at 7:00 AM ET for those registered for the event and will be available on the Events page in the Investors section of the Company’s website (outlooktherapeutics.com). The webcast replay will be archived for 90 days following the event.

Caladrius Biosciences to Present at the H.C. Wainwright Global Investment Conference

On May 18, 2022 Caladrius Biosciences, Inc. (Nasdaq: CLBS) ("Caladrius" or the "Company"), a clinical-stage biopharmaceutical company dedicated to the development of innovative therapies designed to treat or reverse disease, reported that David J. Mazzo, Ph.D., President and Chief Executive Officer of Caladrius, will present a corporate overview at the H.C. Wainwright Global Investment Conference being held both virtually and in-person at the Fontainebleau Miami Beach Hotel in Miami, FL on May 23-26, 2022 (Press release, Caladrius Biosciences, MAY 18, 2022, View Source [SID1234614927]).

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Dr. Mazzo’s presentation will be delivered in-person and is scheduled for Wednesday, May 25, 2022 at 9:30 a.m. Eastern time. For more information on the conference and how to register, please contact your H.C. Wainwright representative or visit www.hcwevents.com/globalconference.

Correction Notice to Press Release Announcing Financial Results For the Fourth Quarter and Full Year 2021 Financial Results and Corporate Update

On May 18 , 2022 Allarity Therapeutics, Inc. (NASDAQ: ALLR) reported that its press release issued under the headline "Allarity Therapeutics Reports Fourth Quarter and Full Year 2021 Financial Results and Provides a Corporate Update" on May 16, 2022, included a typographical error in the section titled "Full Year 2021 and Recent Highlights", describing the size of the debt cancellation which should have read "$971 thousand" instead of "$971 million (Press release, Allarity Therapeutics, MAY 18, 2022, View Source [SID1234614870])." The corrected paragraph is set forth below:

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Full Year 2021 and Recent Highlights

In March 2022, entered into two agreements amending the LiPlaCis program. As a result of this amendment, Allarity will be exempt from any future financial obligation associated with the further development of LiPlaCis, including the cancellation of outstanding liability of $971 thousand. Allarity will also maintain its ability to receive possible future milestone payments of up to $3.5 million